"71904-200-01" National Drug Code (NDC)

Pombiliti 1 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
(AMICUS THERAPEUTICS US, LLC)

NDC Code71904-200-01
Package Description1 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Product NDC71904-200
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePombiliti
Proprietary Name SuffixAtga
Non-Proprietary NameCipaglucosidase Alfa-atga
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20231011
Marketing Category NameBLA
Application NumberBLA761204
ManufacturerAMICUS THERAPEUTICS US, LLC
Substance NameCIPAGLUCOSIDASE ALFA
Strength105
Strength Unitmg/1

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